Background Adjuvant combination chemotherapy with cyclophosphamide,methotrexate, and fluorouracil was administered after radicalmastectomy for primary breast cancer with histologically positiveaxillary lymph nodes to assess whether it would improve treatmentoutcome as compared with surgery alone. Here we report a 20-yearfollow-up of this investigation.
Methods In 1973 we began a trial involving 386 women who wererandomly assigned to receive either no further treatment afterradical mastectomy (179 women) or 12 monthly cycles of adjuvantcombination chemotherapy (207 women). All patients were admittedto the Istituto Nazionale Tumori in Milan, Italy. Adjuvant chemotherapywas delivered in the outpatient clinic of the Division of MedicalOncology.
Results After a median follow-up of 19.4 years, the patientsgiven adjuvant combination chemotherapy had significantly betterrates of relapse-free survival (unadjusted relative risk ofrelapse, 0.71; 95 percent confidence interval, 0.56 to 0.90;P = 0.004; adjusted relative risk, 0.65; 95 percent confidenceinterval, 0.51 to 0.83; P<0.001) and total survival (unadjustedrelative risk of death, 0.78; 95 percent confidence interval,0.62 to 0.99; P = 0.04; adjusted relative risk, 0.76; 95 percentconfidence interval, 0.60 to 0.97; P = 0.03). With the exceptionof postmenopausal women, a benefit from adjuvant chemotherapywas evident in all subgroups of patients.
Conclusions The long-term results of this trial of adjuvantcombination chemotherapy confirm our preliminary observationsof the effectiveness of the treatment in women with node-positivebreast cancer.
Source Information
From the Division of Medical Oncology, Istituto Nazionale Tumori, Via Venezian 1, 20133 Milan, Italy, where reprint requests should be addressed to Dr. Bonadonna.
Adjuvant Chemotherapy in Breast Cancer
Del Mastro L., Costantini M., Bianco A. R., Newman M. D., Evans R. A., Bonadonna G., Valagussa P., Henderson I. C.
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N Engl J Med 1995;
333:596-597, Aug 31, 1995.
Correspondence
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